FDA clears allograft, autograft use in Xtant Medical’s Irix-C cervical cage: 5 highlights

Belgrade, Mont.-based Xtant Medical earned FDA clearance to use autografts and/or allografts in its Irix-C cervical cage.

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Here are five highlights:

 

1. The clearance also expanded the range of allowable levels from C3-T1 to C2-T1.

 

2. Before this clearance, the Irix-C cervical cage was only usable with autogenous bone graft.

 

3. Xtant’s 3Denim and patented OsteoSponge, both allografts, will work with Irix-C.

 

4. OsteoVive, a cellular allograft, may also be used with Irix-C.

 

5. The Irix-C Cervical Integrated Fusion System is a standalone cervical intervertebral fusion device designed for degenerative disc disease treatment.

 

More articles on devices:
Filling a biologic void — Pinnacle Spine’s CEO Zach Sowell on the pioneering bone graft technology
FDA approves full-body MRI for St. Jude Medical’s Proclaim Elite SCS System: 5 key points
1st cases performed with Xtant Medical’s Xspan Laminoplasty Fixation System: 5 highlights

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